The Janssen COVID -19 vaccine has been granted Emergency Use Approval (EUA) by the FDA. This is the third COVID-19 vaccine to be granted EUA following vaccines produced by Pfizer-BioNTech and Moderna. Unlike the Pfizer-BioNTech and Moderna vaccines which utilized a mRNA flatform, the Janssen vaccine is a non-replicating viral vector vaccine. This recombinant replication-incompetent adenovirus type 26 (Ad26) vector encodes the stabilized prefusion spike glycoprotein of SARS-CoV-2.
This is the third vaccine available for the SARS-CoV-2 virus. Similar to the Pfizer-BioNTech and Moderna vaccines, the Janssen COVID-19 vaccine has been shown to be effective and to have a reliable safety profile. Interim analysis of a phase 3 trial of the Janssen vaccine showed an overall efficacy of 66.3% against symptomatic, laboratory-confirmed COVID-19 from ≥14 days after vaccination with the Janssen COVID-19 vaccine while vaccine efficacy against hospitalization ≥14 days after vaccination was 93.1%. This review will focus on the Janssen vaccine.
For the Pfizer-BioNTech and Moderna vaccines, please see the previously conducted review of the two mRNA vaccines approved for use. Additional review information will be provided as other vaccines for SARS-CoV-2 are granted EUA status.
What severity of COVID-19 would you recommend use of this medication?
COVID-19 prevention in those:
- 18 years and older.
- Janssen plans to conduct trials enrolling ages down to 12 years old and then after begin a study that includes newborns and adolescents.
Would you recommend restricting this medication in some way
The Janssen COVID-19 vaccine is only available through federal distribution via Emergency Use Approval (EUA) by the FDA. M Health Fairview will follow Minnesota Department of Health guidance for prioritization of populations for vaccine administration.
Based on the current literature, what dosing is recommended?
Janssen COVID-19 vaccine: Single dose of 0.5 mL, 5×1010 viral particles/dose (1-dose per series).
Is drug monitoring required? If so, what is suggested?
- Recipients should be monitored for adverse effects for 15-30 minutes based on risk for allergic reactions based on CDC recommendations in Appendix A.
- Vaccine administration errors, serious adverse events (even if it is uncertain whether the vaccine caused the event), cases of Multisystem Inflammatory Syndrome, and cases of COVID-19 that result in hospitalization or death are reportable.
- Events should be reported through the Vaccine Adverse Effect Reporting System (VAERS). Information on how to submit a report is available at VAERS or 1-800-822-7967.
Supply and procurement consideration: Is treatment currently available for use in our system, and if so are shortages anticipated? Are there currently restrictions or other barriers?
Currently available through federal and state distribution only.
Considerations in Special Populations
The following recommendations are based on the interim recommendations from the Centers for Disease Control (CDC) and Advisory Committee on Immunization Practices (ACIP) unless specified otherwise.
Are there recommendations for pregnant and/or lactating persons?
- Data on the safety of COVID-19 vaccines in this population is limited.
- No female reproduction or fetal, embryonal, or postnatal development safety concerns were demonstrated in animals that received the Janssen COVID-19 vaccine before or during gestation.
- The adenovirus vector platform used in the Janssen COVID-19 vaccine has also been used for other Janssen vaccine development programs that have included pregnant people vaccinated during any trimester, including in a large-scale Ebola vaccination trial. No adverse pregnancy-related outcomes—including infant outcomes—were determined to be related to the vaccine in these trials.
- There are no data on the safety of COVID-19 vaccines in lactating people or the effects of COVID-19 vaccines on the breastfed infant or milk production or excretion. Because non-live vaccines pose no risk for lactating people or their infants, COVID-19 vaccines are also not thought to be a risk. Therefore, lactating people may choose to be vaccinated.
- ACIP recommends those that are part of a group that is recommended to receive a COVID-19 vaccine (e.g., healthcare personnel) may choose to be vaccinated
- The American College of Obstetrics and Gynecology (ACOG) advised that vaccination should not be withheld from those that are pregnant or breastfeeding and meet ACIP prioritization criteria
- Pregnancy testing should not be required prior to vaccination
- Janssen has plans to enroll 824 pregnant participants in a phase 2 placebo-controlled trial of its COVID-19 vaccine
Are there recommendations for immunocompromised persons?
- People with HIV infection or other immunocompromising conditions or people who take immunosuppressive medications or therapies might be at increased risk for severe COVID-19.
- No data are available to establish COVID-19 vaccine safety and efficacy in these groups. However, the currently authorized COVID-19 vaccines are not live vaccines and therefore can be safely administered to immunocompromised people.
- People with stable HIV infection were included in the COVID-19 vaccine clinical trials, though data remain limited.
- Immunocompromised people can receive COVID-19 vaccination. Data are currently insufficient to inform optimal timing of COVID-19 vaccination among people who are planning to receive immunosuppressive therapies. However, based on general best practices for vaccination of immunocompromised people, ideally COVID-19 vaccination should be completed at least two weeks before initiation of immunosuppressive therapies.
- At this time, re-vaccination is not recommended after people who received COVID-19 vaccines during chemotherapy or treatment with other immunosuppressive drugs regain immune competence.
- On 12/17/20, the American Society of Clinical Oncology (ASCO) and Infectious Diseases Society of America (IDSA) held a webinar to discuss the role of vaccination in patients with cancer.
- All members of the panel acknowledged that there is little to no data to guide practice at this time and decisions should be made after a risk-benefit analysis which they felt will often lean towards the benefits of vaccinations.
- Additional discussion points included:
- Rates of viral transmission in the patient’s community may be a consideration in weighing the risks and benefits of vaccination.
- For those soon to be off cytotoxic chemotherapy in 2-3 months, consider waiting to vaccinate for better immune response.
- For those on maintenance chemotherapy that is less cytotoxic, benefit of vaccination likely outweighs risk during therapy.
- For those on chronic cytotoxic chemotherapy, immune response due to vaccination may be worse than when off cytotoxic chemotherapy, but any immune response they may have to the vaccine may be better than none.
- Autologous and allogeneic stem cell transplant patients will likely be eligible if they are further out from transplant and without history of GVHD. There may be a large variability in timing (+60 days to +6 months) of when patients receive vaccination depending on where the patient receives care, the provider, the patient’s other medical comorbidities, risk of community transmission, etc.
- The Transplantation Society’s (TTS) recommendations are similar and suggest vaccination between the 3rd and 6th month post-transplant weighing the risk of the rate of transmission in the community against the potential for better vaccine response when the patient is in the latter months of the 3-6 month post-transplant window.
- There is no data to change the recommended vaccination schedule/dose for these patients.
- The Transplantation Society (TTS) has given recommendations for patients with solid organ and hematopoietic stem cell transplants. These include:
- Transplant recipients should be vaccinated with any COVID-19 vaccine available (except live attenuated and replicating viral vector vaccines) as soon as they are available.
- The Janssen COVID-19 vaccine is a non-replicating viral vector vaccine and is okay to be given.
- Vaccination should be offered irrespective of past infection or antibodies.
- For solid organ transplant recipients, the ideal timing of vaccination is uncertain. Vaccination should be delayed at least one month from transplant surgery.
- For hematopoietic stem cell transplant recipients, vaccination should be offered between the 3rd and 6th month post-transplant weighing the risk of the rate of transmission in the community against the potential for better vaccine response when the patient is in the latter months of the 3-6 month post-transplant window.
- Transplant candidates may be vaccinated.
- COVID-19 vaccines should be separated from other vaccines by at least 2 weeks as concomitant administration has not been studied.
- Consider prioritizing household contacts of transplant recipients as transmission rates within households are high.
- Response to most vaccines are less robust in transplant patients compared with healthy persons. Recent use of T- and B- cell depletion agents have also been associated with muted immune responses to vaccination.
- Transplant recipients who have received the COVID-19 vaccination should continue to observe all current preventative measures.
- Transplant recipients should be vaccinated with any COVID-19 vaccine available (except live attenuated and replicating viral vector vaccines) as soon as they are available.
- Janssen plans to enroll immunocompromised patients later in 2021.
Are there recommendations for those with autoimmune diseases?
- No data are currently available regarding safety and efficacy, though these persons were eligible for enrollment in clinical trials.
- Those without contraindications may receive any authorized COVID-19 vaccine.
- At this time, re-vaccination is not recommended after immune competence is regained in persons who received a COVID-19 vaccine during chemotherapy or treatment with other immunosuppressive drugs.
Are there recommendations for those with a history of Guillain-Barré syndrome (GBS)?
- As of 3/5/21, one case of GBS was reported in a participant in the vaccine group in the Janssen COVID-19 vaccine clinical trial, compared to one GBS case among those who received placebo.
- With few exceptions, ACIP’s general best practice guidelines for immunization does not include history of GBS as a contraindication or precaution to vaccination.
- Those without contraindications may receive COVID-19 vaccination.
Are there recommendations for those with Bell’s palsy?
- Cases of Bell’s palsy were reported following vaccination of participants in the COVID-19 vaccine clinical trials.
- The FDA does not consider these to be above the frequency expected in the general population and has not concluded these cases were causally related to vaccination.
- Those without contraindications may receive a COVID vaccination.
Are there recommendations for adolescents?
- The Janssen COVID-19 EUA approval is for those 18 and older.
- Janssen is currently conducting Phase2a clinical trials for use in adolescents. This stage of the study is including adolescents 12 to 17 years of age but plans to expand the study to include newborns and children younger than 12.
Are there recommends for the risk of thrombosis after vaccine administration?
- The CDC and FDA have identified 28 cases of thrombosis (or clots) with thrombocytopenia syndrome (TTS). A particularly rare and dangerous blood clot in the brain, known as cerebral venous sinus thrombosis (CVST) have been identified in a portion of these cases.
- The initial cases involved mostly women between the ages of 18 and 48, however, now cases in males have been reported.
- For all women, this is a rare adverse event. For women 50 years and older and men of all ages, the adverse event is even more rare.
- Symptoms occurred 6 to 15 days after vaccination.
- The American Society of Hematology agree with the CDC panel that the risk of COVID-19 disease, including thrombosis, far outweighs the extremely rare risk of TTS associated with highly efficacious vaccines.
- No information to date on any increased risk for TTS in patients with blood diseases and/or pre-existing risk factors for thrombosis or autoimmunity.
- For more information for identifying and treating suspected TTS in the setting of recent J&J vaccine.
Considerations for those with history of, known active infection or exposure to SARS-CoV-2:
Are there recommendations for those with a current or prior history of SARS-CoV-2 infection?
- Data from clinical trials indicate that the currently authorized COVID-19 vaccines can be given safely to people with evidence of a prior SARS-CoV-2 infection and should be offered vaccination regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection.
- Viral testing to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection is not recommended for the purposes of vaccine decision-making.
- Vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they have met criteria to discontinue isolation.
- While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. Thus, while vaccine supply remains limited, people with recent documented acute SARS-CoV-2 infection may choose to temporarily delay vaccination, if desired, recognizing that the risk of reinfection and, therefore, the need for vaccination, might increase with time following initial infection.
Are there recommendations for those with a known SARS-CoV-2 exposure?
- No data are currently available for use as post-exposure prophylaxis.
- Because the median incubation period of COVID-19 is 4–5 days, it is unlikely that a dose of COVID-19 vaccine would provide an adequate immune response within the incubation period for effective post-exposure prophylaxis.
- People in the community or in outpatient settings who have had a known COVID-19 exposure should not seek vaccination until their quarantine period has ended to avoid potentially exposing healthcare personnel and others during the vaccination visit.
- Residents or patients with a known COVID-19 exposure in congregate healthcare settings (e.g., long-term care facilities) or congregate non-healthcare settings (e.g., correctional and detention facilities, homeless shelters) may be vaccinated.
- People residing in congregate settings (healthcare and non-healthcare) who have had an exposure and are awaiting SARS-CoV-2 testing results may be vaccinated if they do not have symptoms consistent with COVID-19.
Considerations for Concomitant Medication Administration or Testing:
Are there recommendations for persons who received passive antibody therapy (monoclonal antibodies, convalescent plasma, hyperimmune SARS-CoV-2 IVIG)?
- No data regarding safety or efficacy is currently available.
- Based on the estimated half-life of such therapies as well as evidence suggesting that reinfection is uncommon in the 90 days after initial infection, vaccination should be deferred for at least 90 days, as a precautionary measure until additional information becomes available, to avoid interference of the antibody treatment with vaccine-induced immune response.
Are there recommendations for persons receiving antibody therapies that are not specific to COVID-19 (Intravenous immunoglobulin, RhoGAM)?
- Administration of mRNA COVID-19 vaccines either simultaneously with or at any interval before or after receipt of an antibody-containing product is unlikely to substantially impair development of a protective antibody response and vaccination may be offered.
Are there recommendations regarding vaccination of those being tested for tuberculosis?
|= Supporting use article||= Neutral Article||= Contradicting use article|
Major Peer-reviewed Studies
Randomized Control Trials:
- Sadoff J, Le Gars M, Shukarev G, et al. Interim Results of a Phase 1-2a Trial of Ad26.COV2.S COVID-19 Vaccine. N Engl J Med. 2021 Jan 13. doi: 10.1056/NEJMoa2034201.
Placebo-controlled, phase 1-2a RCT. Patients in cohorts 1 and 3 were randomized 1:1:1:1:1 to receive one of five vaccination groups: low dose (5×1010 viral particles) followed by low dose, low dose followed by placebo, high dose (1×1011 viral particles) followed by high dose, high dose followed by placebo, and placebo followed by placebo.
Vaccine Clinical Trials
- Multiple Phase 3 clinical trials are in progress including ENSEMBLE and ENSEMBLE 2.
- Interim analysis of the ENSEMBLE clinical trial, an ongoing phase 3 randomized, stratified, double-blind, placebo-controlled trial of the single-dose Janssen vaccine with 44,325 participants over 18 years of age from 8 countries (United States, South Africa, Brazil, Chile, Argentina, Colombia, Peru, Mexico), is supportive of the vaccine’s use.
Is there a need for additional or booster doses (i.e. greater than the 1 dose recommended in the package insert)?
- The need for and timing of booster doses has not been established. No additional doses beyond one-dose series are recommended at this time.
Are the current COVID-19 vaccines considered interchangeable?
- Products are not interchangeable, and recipients should receive the same product for all doses to complete a series. Safety and efficacy of mixed-product series have not been evaluated.
Can a patient who received one dose of an mRNA COVID-19 vaccine receive the Janssen COVID-19 vaccine?
- The safety and efficacy of the Janssen COVID-19 vaccine administered after an mRNA COVID-19 vaccine has not been established. However, in limited, exceptional situations where a patient received the first dose of an mRNA COVID-19 vaccine but is unable to complete the series with either the same or different mRNA COVID-19 vaccine (e.g., due to contraindication), a single dose of Janssen COVID-19 vaccine may be considered at a minimum interval of 28 days from the mRNA COVID-19 vaccine dose.
Are there contraindications to receipt of Janssen COVID-19 vaccine?
- Yes, do not administer the Janssen COVID-19 vaccine to individuals with a known history of severe allergic reaction (e.g. anaphylaxis) to any component of the Janssen COVID-19 vaccine (including polysorbate 80).
- For a list the vaccine components, see Appendix C.
- The Janssen vaccine does not contain any preservatives, latex, eggs, gelatin, or pork products.
Can a person with a contraindication to a mRNA COVID-19 vaccine receive the Janssen COVID-19 vaccine?
- A person with a contraindication to one type of the currently authorized mRNA COVID-19 vaccines has a precaution to the other (e.g., Janssen viral vector). However, because of potential cross-reactive hypersensitivity between ingredients in mRNA and Janssen COVID-19 vaccines, consultation with an allergist-immunologist should be considered to help determine if the patient can safely receive vaccination.
- Polyethylene glycol (PEG) is an ingredient in both mRNA COVID-19 vaccines, and polysorbate 80 is an ingredient in Janssen COVID-19 vaccine. PEG and polysorbate are structurally related, and cross-reactive hypersensitivity between these compounds may occur.
Does taking an antipyretic or analgesic medication (acetaminophen or NSAIDs) affect production of antibodies?
- Antipyretics or analgesics may be taken for the treatment of post-vaccination local or systemic symptoms if medically appropriate
- Routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not recommended, as information on the impact of such use on mRNA COVID-19 vaccine-induced antibody responses is not available at this time
What steps should be taken if a vaccine administration error or deviance from the Emergency Use Authorization administration recommendations are made?
- The CDC has made recommendations for various administration errors and deviances that may occur.
Can the Janssen COVID-19 vaccine be given at the same time as other vaccines?
- The vaccine series should routinely be administered alone with a minimum interval of 14 days before or after administration with any other vaccine.
- However, COVID-19 and other vaccines may be administered within a shorter period in situations where the benefits of vaccination are deemed to outweigh the potential unknown risks of vaccine coadministration (e.g., tetanus toxoid-containing vaccination as part of wound management, measles or hepatitis A vaccination during an outbreak) or to avoid barriers or delays to COVID-19 vaccination (e.g., in long-term care facility residents or healthcare personnel who received influenza or other vaccinations prior to/upon admission or onboarding)
- If COVID-19 vaccines are administered within 14 days of another vaccine, doses do not need to be repeated for either vaccine.
What are the rates of allergic reaction to the Janssen COVID-19 vaccine?
- One case of anaphylaxis in an ongoing open-labeled study in South Africa has been reported following the Janssen COVID-19 vaccine.
- Interim results of a large (44,325 participants) phase 3 randomized, double-blind, placebo control trial of the single-dose Janssen COVID-19 vaccine report no cases of anaphylactic reactions around the time of vaccination.
Are there any lab tests that may aid characterization of severe allergic reactions?
- No specific lab tests can definitively diagnose the cause of a severe allergic reaction
- Two commercially available labs tests, Tryptase (a mast cell marker) and SC5b-9 (a terminal complement marker) may help better characterize a severe allergic reaction
- Additional information about proper collection and interpretation can be found here.
Does vaccination affect transmission of the virus? How long does protection from vaccination last?
- Data regarding transmissibility and protection duration is limited.
- Vaccinated persons should continue to follow all current guidance to protect themselves and others. This includes wearing a mask, staying at least 6 feet away from others, avoiding crowds, washing hands often, following CDC travel guidance, following quarantine guidance after an exposure to someone with COVID-19, and following any applicable workplace or school guidance, including guidance related to personal protective equipment use or SARS-CoV-2 testing.
Does the vaccine provide protection against variant strains of the SARS-CoV-2 virus?
- The CDC is tracking variants that are circulating globally.
- Efficacy of the Janssen COVID-19 vaccine demonstrated in the clinical trial reflected protection against several emerging SARS-CoV-2 variants of concern, including the Wuhan-H1 variant D614G (predominant in the United States), the B.1.351 variant (predominant in South Africa), and a P.2 variant (predominant in Brazil).
- Strain sequencing analyses of COVID-19 cases in the study is being performed, and as of February 12, 2021, 71.7% of cases have been sequenced.
- In the United States, 73.5% of cases have been sequenced, of which 96.4% were identified as SARS-CoV-2 Wuhan-H1 variant D614G.
- Those who have been vaccinated should continue to follow local and national guidance.
How should SARS-CoV-2 test results be interpreted after vaccination?
- Prior receipt of a COVID-19 vaccine will not affect the results of SARS-CoV-2 viral tests (nucleic acid amplification or antigen tests)
- Currently available antibody tests assess IgM and/or IgG to one of two viral proteins (spike or nucleocapsid)
- Both COVID-19 vaccines contain mRNA are constructed to encode the spike protein, a positive test for spike protein IgM/IgG could indicated either prior infection and/or vaccination
- To evaluate for prior infection in an individual with a history of COVID-19 vaccination, a test specifically evaluating IgM/IgG to nucleocapsid protein should be used
Should vaccine response be assessed using antibody tests?
- Antibody testing is not currently recommended to assess for immunity to COVID-19 following COVID-19 vaccination
- Antibody testing is not recommended to determine a person’s eligibility for the COVID-19 vaccine
For vaccinated patients who subsequently develop COVID-19, should treatment decisions be altered?
- Treatment decisions (including use of monoclonal antibodies, convalescent plasma, antiviral treatment, or corticosteroid administration) or timing of such treatments should not be impacted by prior receipt of COVID-19 vaccines
- If a person is fully vaccinated (i.e., ≥2 weeks after completion of a two-dose mRNA series or single dose of Janssen vaccine) and tests positive for SARS-CoV-2, healthcare providers and local health departments are encouraged to request the specimen be held and to report the case to their state health department. CDC will work with the state health department to collect information about the case. In addition, information about these cases should be reported to VAERS.
What if my patient has complex COVID-19 vaccine safety concerns that are not readily addressed in the CDC guidance?
- The CDC’s Clinical Immunization Safety Assessment (CISA) Project is a national network of vaccine safety exports from the CDC’s Immunization Safety Office (ISO), seven medical research centers, and other partners can be consulted through CISA COVIDvax
- This request can be made through CDC-INFO by:
- Calling 800-CDC-INFO (800-232-4636), or
- Submitting a request via CDC-INFO webform
- Janssen Vaccine EUA
- Answering Vaccine Recipients' Questions
- Minnesota Department of Health - COVID-19 Vaccine
- Advisory Committee on Immunization Practices (ACIP) Vaccine Recommendations
- Interim Clinical Considerations for use of COVID-19 Vaccine
- Includes information about co-administration of vaccines, vaccination of special populations, considerations while assessing risks/benefits of vaccination, etc.
- Interim Guidelines for COVID-19 Antibody Testing
- NEJM FAQ
- Stay Safe MN
- CDC MMWR
- Pfizer-BioNTech Vaccine EUA
- Moderna Vaccine EUA